The FDA Law Blog

NOVEMBER 11, 2024

Along with the proposed order, FDA issued as a supporting document the “ Scientific Review Supporting Proposed Administrative Order ” in which it describes the scientific data on the efficacy, pharmacology, and safety of oral PE underlying its determination to issue the proposed order. a); OTC Monograph M012: § M012.20.

FDA 108

FDA Documentation Dosage 108

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” September 2006. The fit-for-purpose and reduced-size POD units promote green manufacturing. Journal of Biotechnology 213 (2015):120–30.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

The Thyroid Pharmacist

DECEMBER 1, 2023

10] In Finland, the incidence of type 1 diabetes in Finnish children increased when the daily recommended dosage of vitamin D was reduced from 4000-5000 IU in 1964, to 400 IU in 1992. Yet, incidences of diabetes in children have been decreasing since 2006, the year Finland decided to fortify all dietary milk products with vitamin D3.

Immunization 98

Immunization Documentation Dosage 98

The Thyroid Pharmacist

JANUARY 20, 2023

I recommend that you closely monitor your thyroid symptoms, thyroid hormones, and thyroid antibodies, and test hormone levels every six to 12 weeks, to ensure your thyroid medication dosage is optimized. 2006 Feb 16;78(12):1287-92. You are pregnant or nursing: Most adaptogens are not to be taken during pregnancy. Int J Ayurveda Res.

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Immunization Compounding Documentation 98